Apparatus and methods for vaccine development using ultrasound technology

ABSTRACT

Method and device for the creation of vaccines using ultrasonic waves, comprised of an ultrasound generator and a transducer to produce ultrasonic waves, is disclosed. The transducer has a specific ultrasound tip depending upon the type of delivery method utilized and depending on the shape of the vial containing the solution of the virus, bacterium, or other infectious agent. The apparatus delivers ultrasonic waves to solution either directly through the insertion of the ultrasound tip into the solution, through a coupling medium adjacent to the vial or near the vial, or through an air or gas medium. The ultrasound waves have the effect of destroying the viable virus, bacterium, or other infectious agent and of releasing the appropriate antigens, thus resulting in a vaccine for that virus, bacterium, or other infectious agent.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to the development of vaccines. Inparticular, the present invention relates to apparatus and methods fordeveloping vaccines using ultrasound technology.

2. Description of the Related Art

Vaccine research and development has seen an increased level ofactivity, especially with the recent development of biodefenseinitiatives. The process of recombinant genetic engineering has provideda potential new approach to creating new and improved vaccines for thetreatment of disease. So far, this approach has met with limited successfor a variety of reasons, and thus many vaccines are still produced viatraditional methodologies.

Most classical vaccines are produced by one of two production methodsthat create either an inactivated (killed) or attenuated (live) vaccineproduct.

Inactivated vaccines (flu, cholera, hepatitis A) are produced by killingthe disease causing microorganism. A number of different methods ofinactivation can be used, including chemicals, irradiation, or heat.These vaccines are considered stable and relatively safe since theycannot revert to the virulent (disease-causing) form. The products oftendo not require refrigeration, a quality that makes them accessible anddesirable to domestic healthcare personnel as well as those indeveloping countries because they are practical for vaccinating peoplewho are in remote locations or involved in highly mobile activities(such as members of the armed force). However, most inactivated vaccinesproduce a relatively weak immune response and must be given more thanonce. A vaccine that requires multiple doses (boosters) may have alimited usefulness, especially in areas where people have limited accessto regular healthcare.

The second classical approach to the production of vaccines is anattenuated or live vaccine (measles, mumps, rubella). Thedisease-causing organism is grown under special laboratory conditionsthat cause it to loose its virulence or disease causing properties.Products prepared in this way require special handling and storage inorder to maintain their potency. These products produce both anti-bodymediated and cell-mediated immunity, and generally they will onlyrequire one booster dose.

While live vaccines do have some higher immune response advantages, thismethod of production has one large drawback. Because the organisms arestill living, it is their nature to change or mutate, causing theseproducts to have a remote possibility that the organisms may revert to avirulent form and potentially cause disease; thus, infection may occureither as a result of exposure while handling/processing the vaccine orafter administration of the vaccine. Therefore, these vaccines must becarefully tested and monitored. Patients who have compromised immunesystems are not usually administered live vaccines.

These two classical approaches to vaccine development and production notonly make up the majority of vaccines in use today, but these approachescontinue to be used in current vaccine development programs, includingthe development of vaccines for HIV/AIDS, newly identified variantstrains of Hepatitis, etc.

Alliger previously discussed using ultrasound technology to createvaccines in U.S. Pats. Nos. 5,582,929 (Alliger) and 6,303,129 (Alliger).Alliger treats substantially viable cells, bacteria, or viruses (i.e.those that are intact and capable of functioning) with ultrasound inorder to make available antigens capable of inducing an immunogenicand/or therapeutic response. Specifically, the treatment of cells andviruses with ultrasound is intended to deactivate the potentiallyharmful cells and viruses and to also disperse the antigens present foruse as a vaccine without further processing.

Alliger recommends that the procedure is conducted at room temperaturewhile maintaining the temperature of the sample containing the microbeagainst which a vaccine is developed between zero and 5 degrees Celsius.The minimization of heat is to prevent the denaturing of the antigens.Denaturating these antigens would limit their ability to produce aspecific immune response, thus diminishing the potential immunogeniceffect of the vaccine. Alliger method is to deliver ultrasound at aspecific frequency, intensity, and duration in order to rupture anddestroy the viruses and bacteria within the sample through cavitation,to disperse the available antigens, and to do so without raising thetemperature of the viruses or bacteria to a level that would denaturethe antigens.

Alliger further states that the time must be sufficient to disrupt theviruses or cells so that no virulent cell structure remains; to do this,Alliger states that one gram of cultured cells may generally requireabout 3 minutes of sonication.

As for sonicating the viruses and cells, Alliger delivered ultrasonicwaves to the microbe sample through a liquid medium at a frequency ofabout 20 kHz to about 40 kHz. He stated that above this frequency rangecavitation intensity is reduced considerably, even at high power inputs,so that cells or viruses may not be fully disintegrated. Alligerspecifically stated that the minimum intensity of the sonic waves shouldbe about 1 watt/sq. cm, and that the preferable intensity level at about20 kHz is 50 to 175 watts/sq. cm.

Alliger failed to mention the role of using different ultrasoundparameters and additional factors such as the volume of thesample/solution containing microorganisms and the geometrical shape ofthe ultrasound tip and vial/container to be used to achieve the mostefficient results in ultrasonic vaccine development. Because of theshortcomings of the classical approaches and Alliger's approach, thereis still a need for apparatus and methods that can produce inactivatedvaccines that can both produce a stronger immune response and that canproduce attenuated microorganisms for vaccine development incapable ofreverting back to a virulent strain.

SUMMARY OF THE INVENTION

The present invention is directed towards improvements of apparatusesand methods for the creation of vaccines using ultrasound wavespreviously researched and tested by the author of this patent in the1980's. Apparatus and methods in accordance with the present inventionmay meet the above-mentioned needs and also provide additionaladvantages and improvements that will be recognized by those skilled inthe art upon review of the present disclosure.

The present invention comprises an ultrasonic generator, an ultrasonictransducer, a sonication tip, and a vial or container of a solution thatcan be sonicated to create vaccines. The solution contained in the vialsis a mass of viruses, bacteria, or other infectious agents. The solutionis sonicated with ultrasound waves to destroy the viable infectiousvirus, bacterium, or infectious agent wile also releasing theappropriate antigens, thus resulting in a vaccine for that virus,bacterium, or other infectious agent.

Ultrasound waves can be delivered to the solution either directlythrough the insertion of the ultrasound tip into the solution, through acoupling medium, or through an air/gas medium. The ultrasound tip thatis used can vary depending upon the type of delivery method chosen.

There are three different types of recommended methods for sonicating asolution by the insertion of the ultrasound tip into the solutionitself. The first method uses a special shaped vial where the ultrasoundtip remains in the same position during the delivery of the ultrasoundenergy while the last two methods utilize movement of the ultrasound tipduring the sonication treatment.

There are also different types of recommended methods for sonicating thesolution through a coupling medium. There can be a medium placed betweenthe tip and the vial, there can be a liquid medium through which todeliver ultrasound waves, or the vial/container itself can be used as amedium if the tips is pressed up against the vial/container.

Based on the ultrasound intensity that is utilized, the sonication timeof the solution can vary. However, the intensity of the ultrasound wavescan be controlled through a variation in the ultrasound parameters suchas the frequency, the amplitude, and the treatment time. The process mayrequire different intensity levels and ultrasound parameters based onthe specific type of virus, bacterium or other infectious agent used tocreate the vaccine and based on the volume of the solution containingmicrobes to be sonicated.

The invention is related to the apparatus and methods of deliveringultrasound energy to viruses, bacteria, or other infectious agents inorder to create a vaccine to treat the virus, bacterium, or infectiousagent.

One aspect of this invention may be to provide a method and device forthe creation of different vaccines.

Another aspect of the invention may be to provide a method and devicefor the creation of vaccines without the risk of toxicity that occurswith other chemical and temperature creation methods.

Another aspect of the invention may be to provide a method and devicefor the creation of high quality vaccines.

Another aspect of the invention may be to provide a method and devicefor the improvement of vaccine creation methods without usingtemperature or chemical influences.

Another aspect of the invention may be to provide a method and devicefor the creation of vaccines with a decreased production time.

Another aspect of the invention may be to provide a method and devicefor the continuous production of vaccines.

Another aspect of the invention may be to provide a method and devicefor the mass production of vaccines.

These and other aspects of the invention will become more apparent fromthe written descriptions and figures below.

BRIEF DESCRIPTION OF THE DRAWINGS

The present Invention will be shown and described with reference to thedrawings of preferred embodiments and clearly understood in details.

FIG. 1 is a perspective view of an ultrasound vaccine development systemwhere the ultrasound tip is inserted into the solution.

FIG. 2 is a cross-sectional view of an ultrasound tip connected via acoupling medium to a vial.

FIG. 3 is a cross-sectional view of an ultrasound tip inserted into aliquid bath with a vial also inserted into the bath to deliverultrasound energy through the liquid to the vial.

FIG. 4 is a cross-sectional view of an ultrasound tip inserted into avial but located at a distance from the solution in the vial.

FIG. 5 are cross-sectional views of example ultrasound tips for use inthe ultrasound vaccine development system.

FIG. 6 are cross-sectional views of example different shaped vials foruse in the ultrasonic vaccine development system where the tip isinserted directly into the solution and sonicates the solution from aconstant position.

FIG. 7 is a cross-sectional view of recommended sonication methods touse with the ultrasound vaccine development system where the tip isinserted into the solution and moves during sonication.

FIG. 8 is a cross-sectional view of a production-line method to use withthe ultrasound vaccine development system.

FIG. 9 is a cross-sectional view of a carousel method to use with theultrasound vaccine development system.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is an apparatus and methods for the development ofvaccines using ultrasound technology. Preferred embodiments of thepresent invention in the context of an apparatus and methods areillustrated in the figures and described in detail below.

FIG. 1 illustrates the vaccine creation apparatus that has an ultrasonicgenerator 1, an ultrasonic transducer 2, a sonication tip 3, and a vial4 or other container in which a solution will be placed. The solution inthe vial or container is a mass of viruses, bacteria, or otherinfectious agents. The solution is sonicated with ultrasound waves todestroy the viable infectious virus, bacterium, or other infectiousagent while also releasing the appropriate antigens, thus resulting in avaccine against that virus, bacterium, other infectious agent. Becausethe resulting vaccine is available for immediate use, the productiontime of vaccines developed through this method is lower than theproduction time of vaccines developed through classical methodsmentioned above.

Ultrasound waves can be delivered to solution either directly throughthe insertion of the ultrasound tip into the solution FIG. 1, through acoupling medium adjacent to the vial FIG. 2 or near the vial FIG. 3, orthrough the air or gas medium FIG. 4.

FIG. 5 shows examples of recommended ultrasound tips that can be useddepending on the type of delivery method. FIG. 5 a is a sphericalultrasound tip 13 and FIG. 5 b is a spherical ultrasound tip 14 thatcontains a central orifice 15. FIGS. 5 c/5 d/5 e/5 f show ultrasoundtips with a flat radiation surface. FIGS. 5 c and 5 e are ultrasoundtips 16 and 17 with a flat radiation surface, and FIGS. 5 d and 5 f areultrasound tips 17 and 20 with flat radiation surfaces and centralorifices 18 and 21. FIGS. 5 g and 5 h show ultrasound tips 22 and 23with a curved radiation surface—FIG. 5 e shows an ultrasound tip 23 witha curved radiation surface and a central orifice 24. The centralorifices of the ultrasound tips shown in FIG. 5 can be used to deliversolution into a vial or container and/or can be used to providesonication during or after delivery of the solution.

FIG. 1 shows direct sonication where the ultrasound tip 3 is insertedinto the vial 4 and into the solution—the recommend tip 3 to use iseither a sphere FIGS. 5 a/5 b, a flat radiation surface FIGS. 5 c/5 d/5e/5 f, a rectangular prism (not shown), or another similar shape orcombination of shapes, with the sphere FIGS. 5 a/5 b as the preferredtip. The most preferred tip is the spherical tip 14 that contains acentral orifice 15; this is because the most preferred treatment methodinvolves the use of a spherical sonication tip where the solution isdelivered into the vial or container through the central orifice.

FIG. 2 shows delivery of ultrasound energy from an ultrasound tip 5through a coupling medium 6 such as liquid, gel, or the glass/plasticvial 7, where the tip 5 is pressed up against the vial 7 orcontainer—the recommended configuration of tip 5 is one that matches theshape of tip 5 to the geometric shape of the vial 7 or container. Forexample, if a spherical vial is to be sonicated, the recommend tip wouldbe a curved-shape tip (not shown) so that the tip would fit around theshape of the vial.

FIG. 3 shows delivery of ultrasound energy from an ultrasound tip 8through a liquid medium 9 where the ultrasound tip 8 is located at adistance from the vial 10—the recommended tip to use is a flat shapedtip FIG. 5 c/FIG. 5 d, with the preferred tip being a flat shaped tipwithout a central office as depicted in FIG. 5 c. For this method, theultrasound tip 8 is placed into the liquid medium 9 and deliversultrasound energy to the vial 10 through the liquid medium 9.

FIG. 4 shows delivery of ultrasound energy from an ultrasound tip 11 toa vial 12 through an air or gas medium—the recommended tip to use is aflat-shaped tip FIG. 5 c/5 d/5 e/5 f, with the preferred tip either FIG.5 c or 5 e. For this delivery method, the ultrasound tip 11 is insertedinto the vial 12 but the tip 11 does not come into contact with thesolution in the vial 12.

FIG. 1 shows delivery of ultrasound energy where the ultrasound tip 3 isinserted into the vial 4 and into the solution—there are three differenttypes of recommended methods for this direct sonication. FIG. 6 showsthe first method that uses a special shaped vial where the ultrasoundtip remains in the same position during the delivery of the ultrasoundenergy, while FIG. 7 shows the last two methods that utilize movement ofthe ultrasound tip during the sonication treatment.

FIG. 6 shows the first method of direct sonication that uses both aspecial shaped vial 26, 28, or 30 and a corresponding ultrasound tip 25,27, or 29 that mirrors the shape of the vial 26, 28, or 30. There arethree different recommended shapes of vials 26, 28, or 30 to use with acorresponding ultrasound tip 25, 27, or 29: the three shapes are FIG. 6a a spherical vial 26, FIG. 6 b a rectangular vial 28, and FIG. 6 c acurved vial 30. With the spherical vial 26 shown in FIG. 6 a, aspherical shaped ultrasound tip 25 is inserted into the bottom of thevial 26. Because the ultrasound tip 25 mirrors the shape of the vial 26,there is an equidistant space between the ultrasound tip 25 and the vial26; this allows for the solution to be sonicated equally, thus resultingin an effective vaccine creation. This same concept of equal sonicationalso applies to the rectangular shaped vial 28 shown in FIG. 6 b. Arectangular-shaped ultrasound tip 27 that mirrors the shape of the vial28 is inserted into the solution, therefore causing the solution to besonicated equally. Finally, the curved shaped ultrasound tip 29 shown inFIG. 6 c can be inserted into a curved shaped vial 30, thereforeallowing for equal sonication of the solution contained in the vial 30.The shapes of the vials 26, 28, or 30 contained in FIG. 6 are therecommend shapes, and the preferred shape is the spherical vial 26;other similar shapes or combinations of shapes of vials and ultrasoundtips can also be utilized.

FIG. 7 shows the second potential method of direct sonication where theultrasound tip 31 is inserted into the bottom of the vial 32 containingthe solution and then the tip rises in a continuous motion 33 as itdelivers ultrasonic energy. After the sonication begins, the ultrasoundtip 31 gradually rises to the top of the solution while deliveringultrasound energy. The ultrasound tip 31 stops its movement and stopsdelivering ultrasound energy after it reaches the top and the entiresolution has been sonicated. This movement during the delivery ofultrasound energy allows for equal sonication of the entire solution,which is effective because it ensures that the harmful cells and virusesare destroyed to prevent toxicity and that the antigens are released.This is more effective than inserting the tip to the bottom of a regularshaped vial and attempting to sonicate the entire solution from oneposition—delivering from one position results in varying sonicationbecause the distance of the solution to the ultrasound tip variesthroughout the vial.

FIG. 7 also shows the third potential method of direct sonication wherethe ultrasound tip 31 is inserted into the bottom of the vial 32containing solution and the tip 31 rises in a step-mode motion 34.Sonication occurs for a brief time and then stops. The ultrasound tip 31is moved slightly higher, and then sonication occurs again. Thisstep-delivery motion 34 is repeated until the tip 31 has moved to thetop and the entire solution has been sonicated Similarly to thecontinuous movement delivery, this method allows for equal sonication ofthe entire solution. This distance between delivery steps in thisstep-mode delivery method can be of equal or varying distances.

FIG. 8 shows a cross-sectional view of a production-line sonicationmethod to use with the ultrasound vaccine development system. Vials 38move down the production line towards the ultrasound tip 35. Uponreaching the tip 35, the tip 35 moves down 37 into the vial 36 tosonicate the solution contained in the vial 36. After sonication, theultrasound tip 35, moves back up 37 and waits until another vial 38moves to the ultrasound tip 37. This process is repeated to sonicatemultiple vials 38. There are multiple options in which the solution canbe inserted in the vials 38. Pre-filled vials 38 can be placed on theline, the ultrasound tip 37 can fill the vial 36 with the solutionthrough a central orifice (not shown) in the ultrasound tip 37, or therecan be a separate delivery mechanism/source or sources (not shown) thatcan fill the vials 38 as they move down the production line and towardsthe ultrasound tip 35. There are also multiple versions of the systemthat can be used—besides using different methods of filling the vialswith solution, one or more ultrasound tips can deliver ultrasonic energyto one or more vials at a time. Furthermore, different methods of directsonication where the ultrasound tip is inserted solution can also beused as described above.

FIG. 9 is a cross-sectional view of a carousel sonication method to usewith the ultrasound vaccine development system. Vials 42 are placed inthe carousel system and rotate around the carousel until they reach theultrasound tip 39. When the vial 40 reaches the ultrasound tip 39, thetip 39 moves down 41 into the vial 40 to sonicate the solution containedin the vial 40. After sonication, the ultrasound tip 39, moves back up41 and waits until another vial 42 moves to the ultrasound tip 39. Thisprocess is repeated to sonicate multiple vials 42. There are multipleoptions in which the solution can be inserted in the vials 38.Pre-filled vials 42 can be placed in the carousel, the ultrasound tip 39can fill the vial 40 with the solution through a central orifice (notshown) in the ultrasound tip 39, or there can be a separate deliverymechanism/source or sources (not shown) that can fill the vials 42 asthey rotate around the carousel and towards the ultrasound tip 39.Furthermore, different methods of direct sonication where the ultrasoundtip is inserted solution can also be used as described above. Theproduction line method and the carousel method are only recommendedsystems to sonicate vials of solution. Additional methods and systemscan be similarly effective.

Based on the ultrasound intensity that is utilized, the sonication timeof the solution can be from fractions of a second and above for bothpulse and continuous wave mode delivery. However, the intensity of theultrasound waves can be controlled through a variation in the ultrasoundparameters such as the frequency, the amplitude, and the treatment time.The recommended frequency range for the ultrasound waves is 16 kHz to 20MHz, with the preferred frequency range of 30 kHz-120 kHz, and the mostpreferred frequency value is 50 kHz. The amplitude of the ultrasoundwaves can be 2 microns and above, with the recommended amplitude to bein range of 3 microns to 250 microns, and the most preferred amplitudevalue is 80 microns. The recommended sonication treatment time is 5-10seconds. The amount of solution in the vial is at least 0.1 grams, andthe preferred amount of solution is 5-10 grams.

The process may require different intensity levels and ultrasoundparameters based on the specific type of virus, bacterium, or otherinfectious agent used to create the vaccine and based on the amount ofthe solution to be sonicated. For example, 5 ml of a solution can besonicated with an ultrasound frequency of 50 kHz, an amplitude of p-p 50microns, an intensity of about 1000 watts/cm², and the sonication timewill take up to 10 seconds based on the type of virus, bacterium, etcsolution. The longer the sonication time of the solution, the lower thelevel of intensity is required; the shorter the sonication time, thehigher the level of intensity is required. The sonication of thesolution can be conducted in different temperature environments, but thepreferred method is to use room temperature.

Although specific embodiments and methods of use have been illustratedand described herein, it will be appreciated by those of ordinary skillin the art that any arrangement that is calculated to achieve the samepurpose may be substituted for the specific embodiments and methodsshown. It is to be understood that the above description is intended tobe illustrative and not restrictive. Combinations of the aboveembodiments and other embodiments as well as combinations of the abovemethods of use and other methods of use will be apparent to those havingskill in the art upon review of the present disclosure. The scope of thepresent invention should be determined with reference to the appendedclaims, along with the full scope of equivalents to which such claimsare entitled.

1) A method for creating vaccines for viruses, bacteria, or otherinfectious agents by using ultrasound technology, comprising the stepsof: a) delivering ultrasonic energy to a vial or container of asolution, where the solution is a mass of viruses, bacteria, or otherinfectious agents; b) wherein the delivery of ultrasonic energy iseither through the direct insertion of the ultrasound tip into thesolution, through an air or gas medium, or through a coupling mediumsuch as a liquid, a gel, or the glass/plastic vial; and i) wherein theultrasound energy has an intensity capable of fully destroying theviable virus, bacterium, or other infectious agent contained in thesolution; ii) wherein the ultrasound energy has an intensity capable ofpartially destroying the viable virus, bacterium, or other infectiousagent contained in the solution; iii) wherein the ultrasound energy hasan intensity capable of releasing the appropriate antigens, thusresulting in a vaccine for that virus, bacterium, or other infectiousagent; or iv) wherein the ultrasound energy is capable of decreasing theproduction time for a vaccine. 2) The method according to claim 1,further including the step of generating the ultrasonic energy withparticular ultrasound parameters indicative of an intensity capablecreating a vaccine. 3) The method according to claim 1, wherein theparticular amplitude is at least 2 microns. 4) The method according toclaim 1, wherein the preferred particular amplitude is in the range of 3microns-250 microns. 5) The method according to claim 1, wherein themost preferred particular amplitude value is 80 microns. 6) The methodaccording to claim 1, wherein the frequency is in the range of 16 kHz-20MHz. 7) The method according to claim 1, wherein the preferred frequencyis in the range of 30 kHz-120 kHz. 8) The method according to claim 1,wherein the most preferred frequency value is 50 kHz. 9) The methodaccording to claim 1, wherein the ultrasonic energy is delivered for aduration of fractions of a second and above. 10) The method according toclaim 1, wherein the ultrasonic energy is delivered for a preferredduration of 5-10 seconds. 11) The method according to claim 1, whereinthe amount of the solution contained in the vial is at least 0.1 grams.12) The method according to claim 1, wherein the preferred amount ofsolution contained in the vials is 5-10 grams. 13) The method accordingto claim 1, wherein the preferred step of delivering ultrasonic energyincludes the step of providing means for delivering the ultrasonicenergy by inserting the ultrasound tip into the solution. 14) The methodaccording to claim 10, wherein the step of delivering ultrasonic energyis achieved by continuous movement of the ultrasound tip in thesolution, whereby the ultrasound tip is inserted into the bottom of thesolution, sonication begins, the ultrasound tip rises to the top whiledelivering ultrasonic energy, and the ultrasound tips stops both movingand delivering ultrasonic energy to the solution after ultrasoundreaches the top and after the ultrasound tip has sonicated the entiresolution. 15) The method according to claim 10, wherein the step ofdelivering ultrasonic energy is achieved by a step-mode delivery methodof the ultrasound tip, whereby the ultrasound tip delivers ultrasoundenergy, stops, and then moves up to deliver ultrasound energy again, andthis process of step-mode delivery is repeated until the whole solutionhas been sonicated. 16) The method according to claim 10, wherein thestep of delivering ultrasonic energy is achieved by the ultrasound tipbeing held in a constant position. 17) The method according to claim 13,wherein the shape of the ultrasound tip mirrors the shape of the vial inwhich the tip is inserted. 18) The method according to claim 1, whereinthe step of delivering ultrasonic energy includes the step of providingmeans for delivering the ultrasonic energy through an air or gas medium.19) The method according to claim 1, wherein the step of deliveringultrasonic energy includes the step of providing means for deliveringthe ultrasonic energy through a coupling medium such as a liquid, a gel,the glass/plastic vial, etc. 20) The method according to claim 16,wherein the shape of the ultrasound tip mirrors the outside shape of thevial in which the tip contacts so that the whole tip is in contact withthe vial either directly or through a coupling medium. 21) The methodaccording to claim 1, wherein the ultrasonic energy destroys the viableviruses, bacteria, or other infectious agents in the solution, releasesthe antigens of the viruses, bacteria, or other infectious agents in thesolution, resulting in the creation of a vaccine with a decreasedproduction time. 22) An apparatus for creating vaccines for viruses,bacteria, or other infectious agents by using ultrasound technology,comprising: a) a generator and a transducer for generating ultrasonicenergy; b) wherein the transducer/tip delivers the ultrasonic energy tothe solution; and i) wherein the ultrasound energy has an intensitycapable of fully destroying the viable virus, bacterium, or otherinfectious agent contained in the solution; ii) wherein the ultrasoundenergy has an intensity capable of partially destroying the viablevirus, bacterium, or other infectious agent contained in the solution;iii) wherein the ultrasound energy has an intensity capable of releasingthe appropriate antigens, thus resulting in a vaccine for that virus,bacterium, or other infectious agent; or iv) wherein the ultrasoundenergy is capable of decreasing the period time from when the solutionis sonicated until the vaccine is available for use. 23) The apparatusaccording to claim 22, wherein a carousel holds the vials of solution tobe sonicated. 24) The apparatus according to claim 23, whereinpre-filled vials of solution are placed into the carousel. 25) Theapparatus according to claim 23, wherein solution is inserted into thevials through an orifice in the ultrasound tip. 26) The apparatusaccording to claim 23, wherein solution is inserted into the vialsthrough a separate delivery mechanism/source or sources in the carousel.27) The apparatus according to claim 23, wherein an ultrasound tip ortips delivers ultrasonic energy to one or more vials of solution at atime, and the carousel rotates after each delivery of ultrasonic energyso that all vials can be sonicated. 28) The apparatus according to claim22, wherein the vials are placed into in a production-line. 29) Theapparatus according to claim 28, wherein pre-filled vials of solutionare placed into the production-line. 30) The apparatus according toclaim 28, wherein solution is inserted into the vials through an orificein the ultrasound tip. 31) The apparatus according to claim 28, whereinsolution is inserted into the vials through a separate deliverymechanism/source or sources in the production-line. 32) The apparatusaccording to claim 28, wherein an ultrasound tip or tips deliversultrasonic energy to one or more vials of solution at a time, and theproduction line moves after each delivery of ultrasonic energy so thatall vials can be sonicated. 33) The apparatus according to claim 22,wherein the generator and transducer generate the acoustic energy withparticular ultrasound parameters indicative of an intensity capable ofcreating a vaccine. 34) The apparatus according to claim 22, wherein theparticular amplitude is at least 2 microns. 35) The apparatus accordingto claim 22, wherein the preferred particular amplitude is in the rangeof 3 microns-250 microns. 36) The apparatus according to claim 22,wherein the most preferred particular amplitude value is 80 microns. 37)The apparatus according to claim 22, wherein the frequency is in therange of 16 kHz-20 MHz. 38) The apparatus according to claim 22, whereinthe preferred frequency is in the range of 30 kHz-120 kHz. 39) Theapparatus according to claim 22, wherein the most preferred frequencyvalue is 50 kHz. 40) The apparatus according to claim 22, wherein theultrasonic energy is delivered for a duration of fractions of a secondand above. 41) The apparatus according to claim 22, where the ultrasonicenergy is delivered for a preferred duration of 5-10 seconds. 42) Theapparatus according to claim 22, wherein the amount of the solutioncontained in the vials is at least 0.1 grams. 43) The method accordingto claim 22, wherein the preferred amount of solution contained in thevials is 5-10 grams. 44) The apparatus according to claim 22, whereinthe transducer contains a radiation surface having a surface areadimensioned/constructed for achieving delivery of the ultrasonic energyto the solution with an intensity capable of creating a vaccine. 45) Theapparatus according to claim 22, wherein the transducer contains aradiation surface where the shape of the radiation surface is either asphere, a rectangular prism, a flat surface, a curved surface, oranother comparable shape or combination of shapes. 46) The apparatusaccording to claim 22, wherein the transducer contains a radiationsurface intended to achieve delivery of the ultrasonic energy to thesolution with an intensity capable of creating a vaccine. 47) Theapparatus according to claim 22, wherein the shape of the peripheralboundary of the radiation surface is either circular, polygonal, oranother comparable shape or combination of shapes. 48) The apparatusaccording to claim 22, wherein the shape of the peripheral boundary ofthe radiation surface is intended to achieve delivery of the ultrasonicenergy to the solution with an intensity capable of creating a vaccine.49) The apparatus according to claim 22, wherein the transducer includesa radiation surface; a selection is made of a size and of a surface areaof the radiation surface, a shape of the peripheral boundary of theradiation surface that is circular, polygonal, or another comparableshape or combination of shapes, and a shape of the radiation surfacethat is either a sphere, a rectangular prism, a flat surface, a curvedsurface, or another comparable shape or combination of shapes; and theparticular ultrasound parameters of the generated ultrasonic energy forachieving delivery of ultrasonic energy to the solution with anintensity capable of creating a vaccine. 50) The apparatus according toclaim 22, wherein the shape of the ultrasound tip mirrors the shape ofthe vial in which it is inserted. 51) The apparatus according to claim22, wherein the transducer is driven by a continuous, pulsed, ormodulated frequency. 52) The apparatus according to claim 22, whereinthe driving wave form of the transducer is selected from the groupconsisting of sinusoidal, rectangular, trapezoidal and triangular waveforms.